Ruling frees FDA to crack down on stem cell clinics

It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use.

It was on this basis that in 2008 the FDA began moves to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx.

Regenerative Sciences challenged the FDA's authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court's ruling.

Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. "This is really round one," he says. "Our position remains that a patient's cells are not drugs."

Regenexx consists of mesenchymal stem cells, which give rise to tissues including bone and cartilage, taken from a patient's bone marrow and grown in culture for about two weeks. Centeno has published a series of case reports describing its use to treat joint problems - but no controlled clinical trials.

"I think it's a good ruling, and I'm glad to see that that the FDA has exercised its muscle on the case," says Christopher Scott, who heads the Program on Stem Cells in Society at Stanford University in California.

Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.

Last month, the Houston Chronicle revealed that FDA inspectors had found multiple violations of good manufacturing practice at Celltex.

So Christopher Scott is ecstatic is he? For the thousands and thousands of patients who have exhausted all conventional means of treatment, what might he suggest? This is another example of a person's rights being eroded. Patients should have the ability to make the decision to use their own stem cells with their own doctors. I smell fear of losing control on the part of Big Pharma, the FDA and those like Mr. Scott. This has been a witch hunt from the Get Go.

For more thoughts on what today's court ruling means, check out my lab's blog post: http://tinyurl.com/d3cjse8. Hint. It's not a witch hunt or great conspiracy, but an effort to protect the patients.

Paul Knoepfler PhD
Associate Professor
UC Davis School of Medicine

shane
on July 26, 2012 10:40 AM

Such a shame if you cant have the right to what is intrinsically a physical part of you.

Stephen Bliss
on July 26, 2012 11:13 AM

How many people die each day because the FDA exists? That would be an interesting study but I doubt it will happen.

When the FDA considers approving a medical treatment, they always err on the side of more years of tests and more millions of dollars testing.

If the FDA allows something that causes a patient to die, congressmen will stand up and yell and demand the FDA be more restrictive. Those strange creatures that call themselves news reporters will make a big scandal about it.

On the other hand if a pill comes on the market that saves 5000 lives a year and was delayed for 5 years by the FDA, causing 25,000 deaths, what happens? Nothing. No scandal, nobody gets fired.

The bottom line is if you want to work for the FDA you must either have no conscience or no brain.

It's estimated to cost 800 million dollars to bring a new drug to market and takes 8 years after the drug has been developed before the company can sell it. That makes new treatments very expensive and prevents new companies from getting into the business.

Albert Salazar
on July 26, 2012 8:45 PM

Thousands and thousands of medical procedures that were risky have been supervised successfully in the past through state medical boards. History is crystal clear on this one – there is no alternative method superior to having new medical procedures progress and allowed in the market more quickly than state medical board approvals. They help thousands of these procedures reach millions that are sick, terminally ill, or disabled more quickly.

The court’s new ruling is saying that the FDA has the right to regulate this medical procedure as a “drug,” which are cells from a patients own body. Following their own protocols from their past, the FDA has never categorized any human body part or cells as a “drug” and have these treatments mandated to the same arduous phases of clinical drug trials. You may ask why? Simple, the FDA has former pharmaceutical executives on the board along with advisors that are ex-pharma executives, and they will conveniently, see adult stem cells as a drug for their own best interest. Not to mention, since big pharma cannot bottle or shelf autologous stem cells, they will never pursue this revolutionary medical procedure for research and profit. Why, because it is a medical procedure and not a manufactured chemical drug! You can't bottle a medical procedure. The irony of it all, undisclosed, big pharma sees it as a medical procedure. This decision without a shadow of doubt is meant to protect the billions of dollars of drug sales!!!

Steve D
on July 27, 2012 3:18 PM

There was once a highly effective drug against morning sickness during pregnancy. It was allowed in Europe but the FDA dragged its feet. The drug was thalidomide. Oh, wait....

Just because they're your own cells doesn't mean you can inject them willy-nilly into your body. It can cause autoimmune problems, for example.

Barbara Hanson
on July 27, 2012 11:24 PM

Steve D - Evidently you aren't aware that patients are getting stem cell therapy everyday all over the world. Any procedure or any drug is not risk free. We get that. Why did you not cite the drugs that have FDA approval that have caused thousands of deaths? This ruling, instead of protecting patients will force more to get treatment offshore or at clinics that operate under the radar. Making the procedure the practice of medicine comes with it the protection that doctors are licensed in the states where they practice and they must carry malpractice insurance. That protects patients far more than denying them treatment. Many patients have tried all conventional means of medicine to try to save or improve their lives to no avail. Now, in the name of "protecting" these patients, they are also going to be denied the use of their own stem cells? Patients aren't buying this for a minute. We see the protection of patents, the research industry, the FDA and Big Pharma with little regard to what happens to any of us.

andrei
on July 28, 2012 4:46 AM

this is great news...such clinics are ripoffs..

Mark
on July 31, 2012 3:17 PM

My mother had the mesenchymal stem cell injections from Dr. Centeno in 2007 to treat avascular necrosis in her knee. She recovered completely and is doing very very well. Her alternative would have been a complete knee replacement and with the risk of infection plus the fact that in time they wear out, the stem cell injections were a much better option.

Shame on the FDA for denying such an effective treatment to those who are suffering. It is cruel and unusual and their decision needs to be challenged and overturned.

Richard D Huhn
on August 1, 2012 11:58 PM

Why don't you get it? The FDA mandate is to protect the population (not any specific individual) from potential commercial drugs and therapeutics that could be injurious (while profitable to the practitioners). The 'stem cell' practitioners could be very rigorous and accomplished researchers or could be home garage-based quacks with no documentation of the processes used to manufacture their product. Who but the FDA is going to sort them out?

Bil Danielson
on August 2, 2012 8:22 PM

I would be interested in data showing conclusively that there has been significant injury to the general public, nation-wide, the extent to which justifies federal intervention. Seems to me the various state medical boards ought to be more than adequate as regulatory control.